Trial Outcomes & Findings for Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (NCT NCT04784091)
NCT ID: NCT04784091
Last Updated: 2023-12-21
Results Overview
The proportion of subjects cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
COMPLETED
PHASE3
412 participants
43 days
2023-12-21
Participant Flow
Participant milestones
| Measure |
Active
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
|
Control
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
209
|
|
Overall Study
COMPLETED
|
193
|
200
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Baseline characteristics by cohort
| Measure |
Active
n=203 Participants
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
|
Control
n=209 Participants
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 15.15 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 13.35 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 14.26 • n=5 Participants
|
|
Age, Customized
< 65 years
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
119 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
186 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
203 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 43 daysThe proportion of subjects cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
Outcome measures
| Measure |
Active
n=203 Participants
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
|
Control
n=209 Participants
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
|
|---|---|---|
|
The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.
|
0.547 Proportion cured
Standard Error 0.035
|
0.122 Proportion cured
Standard Error 0.023
|
SECONDARY outcome
Timeframe: 43 daysThe proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
Outcome measures
| Measure |
Active
n=203 Participants
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
|
Control
n=209 Participants
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
|
|---|---|---|
|
The Proportion of Participants With Their Demodex Mites Eradicated.
|
0.499 Proportion eradicated
Standard Error 0.036
|
0.14 Proportion eradicated
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 43 daysThe proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Outcome measures
| Measure |
Active
n=203 Participants
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
|
Control
n=209 Participants
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
|
|---|---|---|
|
The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score
|
0.187 Proportion cured
Standard Error 0.028
|
0.039 Proportion cured
Standard Error 0.014
|
SECONDARY outcome
Timeframe: 43 daysThe proportion of participants cured based on erythema where cure is defined as having a normal eyelid erythema of the analysis eye at day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Outcome measures
| Measure |
Active
n=203 Participants
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
|
Control
n=209 Participants
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
|
|---|---|---|
|
The Proportion of Participants Cured Based on Erythema Score.
|
0.303 Proportion cured
Standard Error 0.033
|
0.091 Proportion cured
Standard Error 0.02
|
Adverse Events
Active
Control
Serious adverse events
| Measure |
Active
n=203 participants at risk
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
|
Control
n=209 participants at risk
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
0.49%
1/203 • 90 Days
|
0.00%
0/209 • 90 Days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/203 • 90 Days
|
0.00%
0/209 • 90 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.49%
1/203 • 90 Days
|
0.00%
0/209 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/203 • 90 Days
|
0.00%
0/209 • 90 Days
|
|
Infections and infestations
Covid-19
|
0.00%
0/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
Other adverse events
| Measure |
Active
n=203 participants at risk
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
|
Control
n=209 participants at risk
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
2.5%
5/203 • 90 Days
|
2.9%
6/209 • 90 Days
|
|
Eye disorders
Dry eye
|
2.0%
4/203 • 90 Days
|
0.96%
2/209 • 90 Days
|
|
Eye disorders
Punctate keratitis
|
2.0%
4/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Eye disorders
Chalazion
|
1.5%
3/203 • 90 Days
|
0.00%
0/209 • 90 Days
|
|
Eye disorders
Conjunctival haemorrhage
|
0.99%
2/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Eye disorders
Conjunctival hyperaemia
|
1.5%
3/203 • 90 Days
|
0.00%
0/209 • 90 Days
|
|
Eye disorders
Eyelid oedema
|
1.5%
3/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
General disorders
Instillation site pain
|
7.9%
16/203 • 90 Days
|
6.2%
13/209 • 90 Days
|
|
Infections and infestations
Hordeolum
|
2.0%
4/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Immune system disorders
Seasonal allergy
|
0.99%
2/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Infections and infestations
Urinary tract infection
|
1.5%
3/203 • 90 Days
|
0.96%
2/209 • 90 Days
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
3/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
|
Investigations
SARS-CoV-2 test positive
|
1.5%
3/203 • 90 Days
|
0.48%
1/209 • 90 Days
|
Additional Information
Mark Holdbrook, Senior Vice-President of Clinical Development
Tarsus Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee It is specified in the protocol that the data generated in this clinical trial, all related information and any materials containing such data and information are the exclusive property of Tarsus Pharmaceuticals, Inc. and are confidential to Tarsus Pharmaceuticals. Also, the investigator or other study-related personnel may not disclose to anyone or use any data, information or materials related to this clinical trial without the express written consent of Tarsus Pharmaceuticals.
- Publication restrictions are in place
Restriction type: OTHER